510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,544 records, page 601 of 1191
FDA device recalls, page 601 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0883-2016Class IIStryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary...Howmedica Osteonics CorpMAY
Z-0882-2016Class IIStryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the...Howmedica Osteonics CorpHSB
Z-0881-2016Class IIStryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary...Howmedica Osteonics CorpMAY
Z-0880-2016Class IIStryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the...Howmedica Osteonics CorpMAY
Z-0879-2016Class IIStryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the...Howmedica Osteonics CorpMAY
Z-0878-2016Class IIStryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary...Howmedica Osteonics CorpMAY
Z-0877-2016Class IIStryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the...Howmedica Osteonics CorpMAY
Z-0876-2016Class IIStryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary...Howmedica Osteonics CorpMAY
Z-0875-2016Class IIStryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary...Howmedica Osteonics CorpMAY
Z-0874-2016Class IIStryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the...Howmedica Osteonics CorpMAY
Z-0873-2016Class IIStryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of...Howmedica Osteonics CorpMAY
Z-0872-2016Class IIStryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the...Howmedica Osteonics CorpMAY
Z-0871-2016Class IIStryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary...Howmedica Osteonics CorpMAY
Z-0870-2016Class IIStryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary...Howmedica Osteonics CorpHSB
Z-0869-2016Class IIStryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization...Howmedica Osteonics CorpMAY
Z-0868-2016Class IIStryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the...Howmedica Osteonics CorpHSB
Z-0867-2016Class IIStryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary...Howmedica Osteonics CorpMAY
Z-0788-2016Class IIEndobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in...Biomet FranceLYC
Z-1034-2016Class IICovidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8...Medtronic, Inc.KNT
Z-1033-2016Class IICovidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5...Medtronic, Inc.KNT
Z-3035-2017Class IILeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD...Magellan Diagnostics, Inc.DOF
Z-3117-2017Class IIHerga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic...Zimmer GmbHHAW
Z-1698-2017Class IIAGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing...AGFA Healthcare Corp.IZL
Z-0865-2016Class IIFlexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC...Cook IncorporatedDYB
Z-0860-2016Class IIHill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered...Hill-Rom Inc.FRJ
Z-0910-2016Class IIOlympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0909-2016Class IIOlympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0908-2016Class IIOlympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscopeIntegrated Medical Systems IncGCQ
Z-0907-2016Class IIOlympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0906-2016Class IIOlympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0905-2016Class IIOlympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscopeIntegrated Medical Systems IncGCQ
Z-0904-2016Class IIOlympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0903-2016Class IIOlympus, Model No. CF-140L, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0902-2016Class IIOlympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0901-2016Class IIOlympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0900-2016Class IIOlympus, Model No. GIF-140, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0899-2016Class IIOlympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0898-2016Class IIOlympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0897-2016Class IIOlympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0896-2016Class IIOlympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0895-2016Class IIOlympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0894-2016Class IIOlympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0893-2016Class IIOlympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0892-2016Class IIOlympus, Model No. GIF-160, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0891-2016Class IIOlympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscopeIntegrated Medical Systems IncGCQ
Z-0890-2016Class IIOlympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscopeIntegrated Medical Systems IncGCQ
Z-0889-2016Class IIOlympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscopeIntegrated Medical Systems IncGCQ
Z-2137-2016Class IIHeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with...Ergoactives, LLCIRT
Z-0861-2016Class IIConvenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector...Centurion Medical Products, LPFPA
Z-1018-2016Class IIICDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack...LivaNova USA, Inc.DWF